FDA publishes Mifeprex Adverse Events Report

FDA publishes Mifeprex Adverse Events Report The FDA recently released its second Mifeprex Adverse Events Report to the public. The report can be seen at: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm Download the pdf found at mid page under “Related Information.” To further inform you, the AAPLOG article summarizing the 2004 FDA release can be found at http://www.aaplog.org/position-and-papers/mifeprex/analysis-of-severe-adverse-events-related-to-the-use-of-mifepristone-as-an-abortifacient-by-harrison-and-gary/ As you are aware, Mifeprex, the abortion pill, is lethal to 95% or more of the unborn that are its target. Lesser known is the fact that it also poses serious risks for the pregnant woman. The FDA safety trials a decade ago found that at 7 wks gestational age, 8% of women required a D&C to complete their abortion (because of heavy bleeding or incomplete AB). At 8 wks, 16% required a D&C, and at 9 wks (63 days), 23% required D&C. The FDA protocol recommends Mifeprex be used within the 7 week limit. However, by common off label usage, the drug is used up to 9 wks—and even that is a guess, since ultrasound is not required prior to Mifeprex usage, and “LMP” is a notoriously inadequate way to judge gestational age, often being 1-2 wks off. So many women taking the drug will be in the 23% category for an urgent D&C. The FDA does collect voluntary Adverse Event Reports on drugs. Here is a summary of the current Mifeprex AER, courtesy of Liberty Counsel: (Note that these are voluntary reports to the drug company, which then passes on what they feel is significant info to the FDA) Abortion Drug RU-486 is Quietly Killing Women Across America The Food and Drug Administration (FDA) quietly released a report that details the dangers for women who are considering using Mifepristone, also known as the abortion drug “RU-486.” The report states that 14 women have died and more than 2,200 women have experienced serious medical problems from the drug in the United States alone. In addition, the complications of this abortion-inducing drug have led 612 women to be hospitalized, of which 339 were required to undergo a major blood transfusion and 256 suffered from a variety of infections. This study also reveals that abortion businesses are misdiagnosing or misusing this drug. In the face of the FDA’s warning against prescribing it to “patients with confirmed or suspected ectopic pregnancy,” there were 58 cases where it was given to women who had an ectopic pregnancy. In spite of serious complications, this drug is continuing to be marketed as “safe” and, according to the Abortion Care Network website, “Many women feel that Mifepristone is private and more natural.” These results reinforce other findings by the FDA, which reported adverse effects associated with RU-486 in 2006. That earlier study showed 1,100 women having experienced serious medical repercussions as a result of taking this abortion drug.